Simple Patient Access Scheme Submitted to NICE for Rapid Review
WATERTOWN, Mass.--(BUSINESS WIRE)--
pSivida Corp. (NASDAQ:PSDV; ASX:PVA), a specialty pharmaceutical company
that is a leader in the development of sustained release ophthalmic drug
treatments, today announced ILUVIEN® , the first sustained release
pharmaceutical product for the treatment of chronic diabetic macular
edema (DME), is now available in the UK for treatment of private pay and
privately insured patients, as reported by its licensee, Alimera
Sciences.
Alimera also reported that it has recently submitted a simple Patient
Access Scheme (PAS) to the United Kingdom's National Institute for
Health and Care Excellence (NICE) for consideration of the guidance
under rapid review. The NICE Appraisal Committee will assess the likely
impact of the ILUVIEN PAS and determine whether an update to NICE's
previously issued final guidance is warranted, according to Alimera. If
the PAS is accepted by NICE, Alimera further reported that ILUVIEN would
be funded for chronic DME patients in England and Wales through the
National Health Service (NHS). Alimera reported that the NICE Appraisal
Committee is scheduled to meet on May 15, 2013 to discuss the ILUVIEN
PAS submission with an expected 30-day review period to follow.
"We are pleased that ILUVIEN is now available in the UK," said Dr. Paul
Ashton, pSivida president and CEO. "This marks the first availability of
a sustained release therapy for patients who suffer from DME and who
have not responded to conventional therapies. We believe it provides a
welcome additional treatment option for retinal specialists in the UK
treating private pay and privately insured patients. We are hopeful that
the Patient Access Scheme will be approved and make ILUVIEN available to
a larger group of chronic DME patients who are considered insufficiently
responsive to available therapies."
ILUVIEN (190 micrograms intravitreal implant in applicator) is a
sustained release intravitreal implant used to treat vision impairment
associated with chronic DME considered insufficiently responsive to
available therapies. Each ILUVIEN implant provides a therapeutic effect
of up to 36 months by delivering sustained sub-microgram levels of
fluocinolone acetonide (FAc). ILUVIEN is injected in the back of the
patient's eye to a position that takes advantage of the eye's natural
fluid dynamics. The applicator employs a 25-gauge needle, which allows
for a self-sealing wound. To date, ILUVIEN has been granted national
licenses for commercialization by six countries, Austria, the United
Kingdom, Portugal, France, Spain and Germany. The national phase in
Italy is currently ongoing. ILUVIEN has not been approved by the United
States Food and Drug Administration.
pSivida has developed three of the four sustained release devices for
retinal diseases that have been approved in either the US or Europe, the
most recent being ILUVIEN. Independently, pSivida is developing an
injectable, sustained release product to treat uveitis affecting the
back of the eye (posterior uveitis) and an injectable, bioerodible
product to treat glaucoma and ocular hypertension in collaboration with
Pfizer.
About pSivida Corp.
pSivida Corp., headquartered in Watertown, MA, develops tiny, sustained
release, drug delivery products designed to deliver drugs at a
controlled and steady rate for months or years. pSivida is currently
focused on treatment of chronic diseases of the back of the eye
utilizing its core technology systems, Durasert™ and BioSilicon™. The
injectable, sustained release micro-insert ILUVIEN® for the treatment of
chronic Diabetic Macula Edema (DME), licensed to Alimera Sciences, Inc.,
has received marketing authorization in Austria, France, Germany,
Portugal, the U.K. and Spain and is awaiting authorization in Italy.
ILUVIEN® for DME has not been approved in the US. pSivida plans to
institute pivotal Phase III clinical trials for the treatment of
posterior uveitis with the same micro-insert as ILUVIEN® for DME. An
investigator-sponsored clinical trial is ongoing for an injectable,
bioerodible micro-insert to treat glaucoma and ocular hypertension.
pSivida's FDA-approved product Retisert® is an implant that provides
long-term, sustained drug delivery to treat posterior uveitis, a chronic
disease of the retina.
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM
ACT OF 1995: Various statements made in this release are
forward-looking, and are inherently subject to risks, uncertainties and
potentially inaccurate assumptions. All statements that address
activities, events or developments that we intend, expect or believe may
occur in the future are forward-looking statements. The following are
some of the factors that could cause actual results to differ materially
from the anticipated results or other expectations expressed,
anticipated or implied in our forward-looking statements: uncertainties
with respect to: the FDA's acceptance of Alimera's resubmission of its
NDA for ILUVIEN® for DME and Alimera's ability to obtain regulatory
approval for, and if approved, to finance, successfully commercialize
and achieve market acceptance of, and generate revenues to pSivida from,
ILUVIEN® for DME in the U.S.; the timing of the commercial launch in
Germany and the UK, any effect of the PAS on the NICE final guidance,
Alimera's ability to finance, achieve additional marketing approvals,
successfully commercialize and achieve market acceptance of, and
generate revenues to pSivida from, ILUVIEN® for DME in the EU; financing
and success of Phase III posterior uveitis trials including efficacy,
side effects and risk/benefit profile of the posterior uveitis
micro-insert; initiation, financing and success of Latanoprost Product
Phase II trials and exercise by Pfizer of its option; development of
products using Tethadur and BioSilicon; initiation and completion of
clinical trials and obtaining regulatory approval of product candidates;
adverse side effects; ability to attain profitability; ability to obtain
additional capital; further impairment of intangible assets;
fluctuations in operating results; decline in royalty revenues; ability
to, and to find partners to, develop and market products; termination of
license agreements; competition and other developments affecting sales
of products; market acceptance; protection of intellectual property and
avoiding intellectual property infringement; retention of key personnel;
product liability; consolidation in the pharmaceutical and biotechnology
industries; compliance with environmental laws; manufacturing risks;
risks and costs of international business operations; credit and
financial market conditions; legislative or regulatory changes;
volatility of stock price; possible dilution; possible influence by
Pfizer; absence of dividends; and other factors described in our filings
with the SEC. Given these uncertainties, readers are cautioned not to
place undue reliance on such forward-looking statements. Our
forward-looking statements speak only as of the dates on which they are
made. We do not undertake any obligation to publicly update or revise
our forward-looking statements even if experience or future changes
makes it clear that any projected results expressed or implied in such
statements will not be realized.
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The President's Blog: http://www.thechairmansblog.com/paul-ashton
In US:
Martin E. Janis & Company, Inc.
Beverly Jedynak,
312-943-1123 or 773-350-5793 (cell)
President
bjedynak@janispr.com
or
In
Australia:
pSivida Corp.
Brian Leedman, +61 (0) 41 228 1780
Vice
President, Investor Relations
brianl@psivida.com
Source: pSivida Corp.
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